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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that the balloon had deflation issue.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was unable to deflate properly and did not enter the non boston scientific guide extension catheter.Consequently, the wolverine was forcibly retracted several times and possibly the balloon was torn due to deflation travel.The procedure was completed with another of the same device.No patient complications reported.
 
Event Description
It was reported that the balloon had deflation issue.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was unable to deflate properly and did not enter the non boston scientific guide extension catheter.Consequently, the wolverine was forcibly retracted several times and possibly the balloon was torn due to deflation travel.The procedure was completed with another of the same device.No patient complications reported.It was further reported that the physician waited 20 seconds for the balloon to delate before pulling back on the device but a part of the device could not be fully deflated.A 7f guide catheter was used during the procedure.No abnormal resistance was encountered while advancing the device in the guide catheter or over the wire.
 
Manufacturer Narrative
A2 - age at time of event: 18 years or older.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12161092
MDR Text Key261316885
Report Number2134265-2021-08913
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/05/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0027087080
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/29/2021
Initial Date FDA Received07/13/2021
Supplement Dates Manufacturer Received07/12/2021
Supplement Dates FDA Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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